Urinary and Sexual Function Before and After Surgical Dec... | NCT02059798

Studies
Urinary and Sexual Function Before and After Surgical Decompression of Cervical Myelopathy

NCT02059798

Sponsor

The Catholic University of Korea

Status

Unknown status

Last Update Posted

Feb 11, 2014Estimated

Enrollment

76Estimated

Phase

Not provided

Conditions

Myelopathy
Neurogenic Bladder
Erectile Dysfunction
Psychosexual Dysfunctions
Sexual Arousal Disorder

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Feb 2016Estimated

Completion Date

Aug 2016Estimated

First Submitted Date

Feb 7, 2014

First Submission Date that Met QC Criteria

Feb 10, 2014

First Posted Date

Feb 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2014

Last Update Posted Date

Feb 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hypotheses:

Decompressive surgery of cervical myelopathy will improve bladder function.

Decompressive surgery of cervical myelopathy will improve sexual function.

Detailed Description

The investigators will enroll consecutive cohort with cervical myelopathy who are scheduled to take surgical decompression of cervical spinal cord, aged between 25 and 65.

The exams for the patients include followings

JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy
VAS (Visual Analog Scale) pain score
IPSS (International Prostate Symptom Score) and IIEF (International Index of Erectile Function) in male patients
FSFI (Female Sexual Function Index) and UDI (Urinary Distress Inventory) in female patients
Bladder compliance, Detrusor leak point pressure, Peak detrusor pressure
Rigidity activity unit of penis

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

76Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Decompression of cervical myelopathy		JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy Compliance Rigidity activity unit

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy	This score will provide patients' conditions at a glance.	6 months after surgery

Secondary Outcomes

Measure	Description	Time Frame
Bladder compliance	This will be provided by urodynamic study, and will show the intactness of Guarding reflex from upper spinal cord tract.	6 months after surgery

Other Outcomes

Measure	Description	Time Frame
Rigidity activity unit of penis	This study will be provided by nocturnal penile tumescence study and will show the intactness of psychogenic erectile pathway.	6 months after surgery
Female sexual function index

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

evidence of progression of motor or sensory nerve
cervical myelopathy in magnetic resonance imaging

Exclusion Criteria:

radical pelvic surgery
pelvic irradiation
evidence of brain damage (dementia, cerebrovascular disease)
evidence of psychotic disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients having cervical myelopathy, aged between 25 and 65

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dong Sup Lee, MD, PhD	Contact	82-31-249-8276		lds@catholic.ac.kr
Ilsup Kim, MD, PhD	Contact	82-31-249-7190		nsman72@hanmail.net

Overall Officials

Name	Affiliation	Role
Ilsup Kim, MD, PhD	The Catholic University of Korea	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Vincent's Hospital, The Catholic University of Korea		Suwon	Gyeonggi-do	442-723	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D013118	Spinal Cord Diseases
D001750	Urinary Bladder, Neurogenic
D007172	Erectile Dysfunction
D020018	Sexual Dysfunctions, Psychological

Ancestor Terms

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D001745	Urinary Bladder Diseases

Browse Leaves

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Browse Branches

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